Kornimate/medical-research-clean huggingface dataset:
abdominal symptom phenotype study in children

Conditions: Irritable Bowel Syndrome (IBS)

Summary: children and adults commonly suffer from recurrent abdominal (stomach) pain. one type is called irritable bowel syndrome (ibs). ibs in adults and children is one of the most common and costly health care problems in the us. some children have pain frequently (recurrent pain) while others rarely have pain. the investigators are conducting this study to help us answer questions about the causes and treatments, and management of ibs in children. the purpose of this study is to find out if there is more than one type of ibs in children. if there is, this will be important in deciding the best treatments. the investigators also want to learn how children with ibs differ from those who do not have recurrent abdominal (stomach) pain.

functional gastrointestinal (gi) disorders (fgids), in particular irritable bowel syndrome (ibs) in adults and children, are among the most common and costly health care problems in the us. ibs disproportionately affects adult women (10-15% in western nations) and adolescent girls. yet, health care providers remain challenged to provide effective clinical management. the etiology of ibs is not well defined and likely multi-factorial. a need to define subgroups of ibs: this study emerges from the claim that identification of patient subgroups will advance our understanding of ibs and ultimately help develop treatment approaches. most studies have lumped together patients with ibs into 2 groups (constipation-, diarrhea-predominant) and tested whether they differ from healthy controls. we propose that a paradigm shift is in order. we should recognize that ibs likely has multiple causes and therefore, multiple expressions. we speculate that by understanding better defined patient subgroups and linking them to newer biomarkers or tests, ultimately will further the understanding of the origins and create effective treatments.

Eligibility criteria:
inclusion criteria: ibs: * age 7-12 years * females * meet criteria for irritable bowel syndrome without evidence of organic disease * developmentally normal * english speaking (as the psychological measures are either not available or validated in spanish) * no other chronic, significant (e.g., diabetes, migraines) medical conditions * no menses controls: * age 7-12 years * females * no abdominal pain * no gi or chronic medical conditions (e.g., diabetes) * developmentally normal * english speaking (as the psychological measures are not available or validated in spanish) * no menses exclusion criteria: * non-english speaking * developmentally or cognitively impaired * males * menses * no mother in the household for administration of the psychological measures * use of any anti-depressants * history of migraines or chronic pain disorders * on narcotics for at least 1 week prior to enrollment * on any nsaids or pain reliever for at least 24 hours prior to enrollment * sought psychotherapy in past 6 months for abdominal pain

Keywords: ibs irritable bowel syndrome abdominal pain urgency bloating diarrhea constipation
comparative effectiveness of antibiotics for respiratory infections

Conditions: Acute Otitis Media; Acute Sinusitis; Group A Streptococcal Pharyngitis

Summary: the purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (artis) in children.

outpatient, artis account for the vast majority of antibiotic exposure to children, and roughly half of these antibiotic prescriptions are inappropriate. although unnecessary antibiotic prescribing for viral infections has significantly decreased, there has been a substantial increase in prescribing of broad-spectrum antibiotics to treat artis when narrow-spectrum antibiotics are indicated. primary care providers, patients, and caregivers would benefit from studies assessing the implications of alternate antibiotic regimens for these common infections. specifically, it remains unclear if treating common artis with broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment with narrow-spectrum antibiotics, particularly considering the increasing threat posed by antimicrobial resistance. because of the lack of large comparative effectiveness studies with patient-centered outcomes addressing this issue, professional guidelines and expert recommendations are conflicting, and, as a result, practice patterns vary considerably. therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common artis in children. to accomplish this, we will perform a prospective cohort study of children receiving antibiotics for arti across a comprehensive pediatric healthcare network. we will conduct telephone interviews with parent's of children who receive antibiotic treatment for an arti. we will assess previously identified patient-centered outcomes included a health-related quality of life measure, occurrence of side effects, missed school/daycare, parent missed commitments and/or required additional childcare and symptoms were still present on day 3 after diagnosis.

Eligibility criteria:
inclusion criteria: we included children between six months and 12 years old, diagnosed with an arti (acute otitis media, acute sinusitis, group a streptococcal \[gas\] pharyngitis) using international classification of diseases diagnosis codes and prescribed an antibiotic. for gas pharyngitis, the child also had a positive rapid streptococcal test. exclusion criteria: * diagnosed with multiple artis * diagnosed with another non-arti bacterial infection * prescribe antibiotics in the past 30 days * non-english speaking families * if gas pharyngitis diagnosis, age \< 3 years

Keywords: antibiotic use effectiveness acute respiratory infections pediatrics
testing a scalable model of care to improve patients access to mental health services after traumatic injury

Conditions: Posttraumatic Stress Disorder; Depression

Summary: the purpose of this study to learn about patients' experience with the trauma resilience and recovery program (trrp) and/or the enhanced care group.

in 2015, our team launched the trauma resilience and recovery program (trrp) at the medical university of south carolina's level i trauma center. trrp is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (step 1), foster symptom self-monitoring and continued education via our automated text messaging system (step 2), screen for ptsd and depression by chatbot or telephone 30 days post-injury (step 3), and provide a referral and warm handoff to mental health services if needed (step 4). the purpose of the proposed study is to examine the clinical and functional impact of trrp over a period of 12 months. we will conduct a randomized controlled trial (rct) with one-year follow up of trrp vs. enhanced usual care (euc) with 350 patients at the george washington university (gwu) hospital, which serves a diverse population of \~2000 trauma center patients per year (15% penetrating mechanism). trained, supervised interviewers blind to study condition will assess clinical and functional outcomes 3-, 6-, and 12-months post-baseline (aim 1). qualitative interviews will be conducted with ≥ 30 patients from underrepresented minority groups (i.e., african american, latinx) as well as ≥ 20 victims of violent trauma (penetrating mechanism) to identify opportunities to strengthen the model to meet the diverse needs of these patients (aim 2). gwu does not currently have an embedded mental health program in place, which will enable us to explore implementation determinants systematically (aim 3).

Eligibility criteria:
inclusion criteria: * english- or spanish-speaking patients ≥ 16 years old who are admitted to george washington university hospital's trauma center and screen positive on the injured trauma survivors screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included. exclusion criteria: * patients who have a glasgow coma scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the montreal cognitive assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. patients with positive substance use screens via gwu's sbirt protocol (\~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. we have found at musc that a high percentage of patients with sbirt- positive screens are nevertheless good candidates for trrp (\>85%), but patients with serious, active substance abuse problems are likely not good candidates for trrp and therefore will be excluded and referred to a substance use treatment center.
initial study with the cnds advanced cervical scan to recalibrate spectral data for use in future screening studies

Conditions: Cervical Disease

Summary: the purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix.

subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with cervical intra-epithelial neoplasia (cin1/2) and women with cin3+, as described in section 6.1, "cervical cytology enrollment targets". after the cervical neoplasia detection system (cnds) test, a sample for hybrid capture 2 human papillomavirus (hpv) testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated. a key component of effective screening studies designed to evaluate new detection modalities is verification of the gold standard comparison by which estimates of sensitivity and specificity are generated. in the case of screening studies in general and studies of cervical disease detection in particular, the avoidance of verification bias is a priority. for the purposes of the proposed study, cin3 or cancer (cin3+) must be verified or adjudicated by multiple histopathologists. results for women with cin1 or cin2 will be confirmed histopathologically and analyzed as a separate subgroup because these lesions often regress to normal in certain populations and tend to cause disagreement among histopathologists. in order to verify absence of disease (i.e., cin1 or less severe), the investigators will not rely on histopathology, as it would not be ethical to perform multiple biopsies or excisional procedures to obtain a tissue sample for histopathology. instead, women will be considered normal if they have negative referral cytology, are free of high risk hpv and are colposcopically normal.

Eligibility criteria:
inclusion criteria: * age 21 or above * able to read or understand and give informed consent * negative pregnancy test or documentation of acceptable birth control * willing to undergo colposcopy, cytology (if required) and hpv testing on day of study * abnormal cytology result within 120 days of cnds test for phase 2 subjects exclusion criteria: * pregnancy * menstruating * previous cervical neoplasia * prior hysterectomy * conditions relating to the cervix that would render the test difficult to perform, including but not limited to: excessive blood or mucus that cannot be removed abnormal congenital cervix unable to tolerate speculum or cnds single use cervical guide

Keywords: spectroscopy hpv
comprehensive patient reported outcomes (pro) management for oncology practice

Conditions: Breast Cancer

Summary: cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. most cancer patients are treated in outpatient settings. patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver. when the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or pros. the questionnaires used to collect this information are called pro instruments. the use of pro instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. the goal of using pro measures is to provide better information to doctors and patients so that the best treatment for patients can be determined. purpose: to reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.


Eligibility criteria:
inclusion criteria: * female, breast oncology patient * breast cancer diagnosis * expected chemotherapy regimen of at least 3-4 months * sufficient cognitive ability and psychological stability in the opinion of treating physician * fluent in spoken and written english * 18 years of age or older * outpatient * life expectancy \> 6 months as estimated by treating physician * informed of the investigational nature of this study and provided informed consent. * has access to either a phone or the internet exclusion criteria: * is not female, nor a breast oncology patient * does not have breast cancer diagnosis * expected chemotherapy regimen is less than 3-4 months * does not have sufficient cognitive ability and psychological stability in the opinion of treating physician * is not fluent in spoken and written english * is younger than 18 years of age * inpatient * life expectancy \< 6 months as estimated by treating physician * is not informed of the investigational nature of this study and does not provide informed consent. * does not have access to either a phone or internet.

Keywords: patient reported outcomes (pro) web-based phone-based breast cancer
bioavailability of iron from savoury food product

Conditions: Healthy; Iron Deficiency

Summary: the study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products


Eligibility criteria:
inclusion criteria: * healthy female subjects; * age \> 18 and \< 40 years at screening; * body weight \<65 kg; * apparently healthy: no medical conditions which might affect study measurements (judged by study physician); * with iron deficiency (serum ferritin \<15µg/l); * currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself; * willing and able to participate in the study; having given a written informed consent. exclusion criteria: * blood donation or significant blood loss over the past 6 months; * reported use of any medically- or self-prescribed diet; * use of medication (except oral contraceptives) * use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study; * is pregnant or will be planning pregnancy during the study period; * is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period; * known gastrointestinal or metabolic disorders; * participation in another clinical trial during the last 30 days prior to the beginning of the study.

Keywords: female subjects
comparison of vacuum assisted closure and saline dressing in patients with diabetic foot ulcers

Conditions: Diabetic Foot

Summary: conventionally diabetic foot is treated with moist wound dressing and antibiotics but recent studies show that vac dressing gives better results as compared to conventional saline dressing in treating diabetic foot ulcers. this may decrease amputations rate, work load on hospitals, hospital stay, repeated hospital admissions, unemployment and can improve patient's quality of life. objective of the study was to compare the effectiveness of vacuum assisted closure therapy with saline dressing in management of diabetic foot ulcers in terms of granulation tissue formation and wound healing.

it was a randomized controlled trial done in department of surgery, mayo hospital,vlahore, pakistan from january 2022 to july 2022. patients divided in two groups, in the vac group (group a), the wound bed was filled with a saline soaked gauze piece after it is thoroughly cleaned. vac was applied by placing sterile pads in two layers with a 16fr ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. the tube was connected to a wall mounted suction device and the pressure was set at -125 mmhg. in the saline group (group b), normal saline dressing was given. this consists of placing a saline soaked gauze piece over the wound bed after cleaning the wound. patients were assessed and followed for wound healing. the primary outcome parameter was time taken to complete wound healing. secondary outcome parameters were granulation tissue formation using a visual score and complication of bleeding, pain, and infection. only healthy granulation tissue which appears pink was considered for scoring assessment. infection was assessed by wound culture sensitivity which was sent every week.

Eligibility criteria:
inclusion criteria: * • diabetic foot ulcer (dfu) patients between the ages of 18 and 60 * patients of both genders * diabetic foot ulcer (dfu) patients whose ulcers are smaller than 15 cm in diameter. exclusion criteria: * • coagulopathy * venous diseases * foot ulcers with underlying osteomyelitis * charcot's joint * peripheral vascular diseases * patients with wegener's grade iv * involving both feet * patients with hiv and chronic liver disease
a study of hsv testing among pregnant women

Conditions: Herpes Simplex; Pregnancy

Summary: the objective of the study is to evaluate the acceptance and effect of type- specific hsv serologic testing of pregnant women on sexual behavior at the end of pregnancy.

the study hypothesis is that women with antepartum testing who are identified as susceptible to hsv-1 or hsv-2 will have reduced unprotected coital activity and reduced unprotected oral-genital activity compared to those who did not receive antepartum testing. the objective of the study is to evaluate the acceptance, and effect of type-specific hsv serologic testing of pregnant women on sexual behavior at the end of pregnancy. upon enrollment, study participants will be randomized into either of two type-specific hsv serologic testing and counseling regimens: * group 1: antepartum and postpartum testing. subjects will be made aware of their antepartum testing results. * group 2: antepartum blood draw and postpartum testing. subjects' specimens will be tested at the same time. women in group 2 will receive information about herpes infection and how to decrease their chance of acquiring infection during pregnancy. subjects will be asked to keep a diary of sexual activity and return to the clinic every 4 weeks until delivery.

Eligibility criteria:
inclusion criteria: * 14 years of age or older * pregnant less than 28 weeks at time of enrollment * no previous hsv serology within the past year * able to comprehend english exclusion criteria: * history of genital herpes * hiv seropositive * any contraindication for sexual activity during pregnancy
chess training as add-on intervention for adolescents with psychiatric and psychosomatic disorders

Conditions: Children and Adolescents Inpatient in Psychiatric Hospital

Summary: in the planned study, the effect of chess training on the cognitive abilities of children and adolescents with psychiatric and psychosomatic illnesses will be investigated in a naturalistic setting. furthermore, the effects on therapy success and quality of life will be determined.despite the thoroughly positive results, crt has not yet been included in the official guidelines as an intervention in standard therapy; this is due, among other things, to too few studies and too little knowledge in the field of child and adolescent psychiatry. the planned study aims to fill the research gap in the field of chess training as an adjunctive intervention in children and adolescents and to provide further evidence on the relevance of crt in child and adolescent psychiatry. the hypotheses of the proposed study are: 1. chess training as a six-week add-on intervention will improve cognitive functioning in adolescents with psychiatric/psychosomatic disorders compared to standard treatment. 2. chess training as a six-week add-on intervention improves quality of life in adolescents with psychiatric/psychosomatic disorders compared to standard treatment. 3. chess training as a six-week add-on intervention positively influences the course of therapy in adolescents with psychiatric/psychosomatic illnesses compared to standard treatment.


Eligibility criteria:
inclusion criteria: * inpatient treatment at the clinic for psychiatry and psychotherapy of childhood and adolescence, zi mannheim * age between 13 and 17 years * sufficient ability to answer questions verbally and in written form * ability to give consent by patients and their parents after detailed verbal and written explanation * consent of patients and parents must be given in paper form exclusion criteria: * date of inpatient admission more than 3 weeks ago * withdrawal of informed consent * severe psychiatric, neurological and internal medical comorbidities

Keywords: cognitive remediation chess training working memory decision making executiv control chess cognitive change quality of life in adolescents